Office of Human Research Ethics SOP 3801: Research Involving Coded Private Information or Biological Specimens

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Office of Human Research Ethics SOP 3801: Research Involving Coded Private Information or Biological Specimens

1. Research Involving Coded Private Information or Biological Specimens

1.1 Biological Specimens

All activities involving the collection of human biological specimens for research purposes, as well as the research use of specimens collected for clinical care, must be conducted under the terms of an IRB approved research protocol. The collection and use of human biological specimens (either identifiable or de-identified) must comply with all applicable laws and regulations for research involving human biological specimens or superseding requirements.

1.2 Regulatory Oversight

Under HHS regulations, a human subject is a living individual about whom an investigator conducting research obtains:

• data through intervention or interaction with the individual, or
• identifiable private information.

Whether research involving biological specimens meets the definition of human subjects research is based on:

1. how the specimens were obtained, and
2. whether the specimens include identifiable private information.

If the specimens are obtained specifically for research purposes, then they have been collected through intervention or interaction with the individual and, thus, the research meets the definition of human subjects research. If the specimens were not collected for research purposes but as part of routine clinical care or other non-research purpose, then the research only meets the definition of human subjects research if the specimens include identifiable private information (See below for policies on coded specimens).

Research involving de-identified newborn blood spots, like research with other de-identified human specimens, is not considered human subjects research under either the pre-2018 Common Rule or the 2018 Common Rule.

1.3 Research Use of Cord Blood from Births at UNC Hospitals

According to UNC Hospitals policy (February 15, 2000), any collection for research use of placental tissue, umbilical cord tissue or cord blood from births at UNC Hospitals will require written consent of the mother. Investigators seeking to acquire such specimens for research use should prepare an IRB application including a consent form. They must also notify the Department of OB/GYN, since protocols involving obstetrical patients also require review by the OB/GYN Department Research Committee and requests for cord blood may need to be prioritized. Investigators will be responsible for making arrangements for obtaining consent and collecting the specimens.

This policy is based on the following considerations:

1. Cord blood and placental tissue are a unique source of stem cells and other biologic materials, with great therapeutic potential. Consequently there is increasing demand.
2. Certain research uses of these tissues already require informed consent. In particular, the recent designation of UNC Hospitals as a collection site for an NHLBI-sponsored Cord Blood Bank for stem cell research will result in approaching most if not all mothers for permission to collect cord blood for this purpose.
3. Certain ethnic groups do not view the placenta and placental blood as waste, but as sacred objects. Using tissues from such persons without their consent would constitute a serious violation of their rights.

U.S. Food and Drug Administration (FDA) regulations do not apply to biological specimens unless they are gathered as part of a clinical investigation involving human subjects or being used to test a medical device. HIPAA does not cover biological specimens but does cover protected health information (PHI) linked to the specimens

Registries are sometimes created by a public authority (e.g., the North Carolina Central Cancer Registry was created by the North Carolina Legislature, see North Carolina General Statute Chapter 130A, Article 7: Chronic Disease). If the research meets the definition of human subjects research, then all of the requirements of this document apply.

1.4 IRB Review

IRB review of research involving biological specimens will be conducted pursuant to applicable regulations and University of North Carolina at Chapel Hill ("UNC-Chapel Hill") Office of Human Research Ethics SOPs (e.g. SOP 701 IRB Review Process).

1.5 Coded Human Data or Biological Specimens

The UNC-Chapel Hill IRB policy is based on the U.S. Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) guidance document entitled, “Guidance on Coded Private Information or Specimens Use in Research” (October 16, 2008). This document:

1. Provides guidance as to when research involving coded private information or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46).
2. Reaffirms OHRP policy that, under certain limited conditions, research involving only coded private information or specimens is not human subjects research.
3. Clarifies the distinction between:
   1. research involving coded private information or specimens that does not involve human subjects, and
   2. human subjects research that is exempt from the requirements of the HHS regulations.
4. References pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens.

Note: The FDA definition of human subjects differs from the Common Rule definition. Use of coded specimens for FDA‐regulated research such as research on In Vitro Diagnostic Devices requires assessment according to the FDA regulations and guidelines. Investigators should contact the IRB office for guidance.

For purposes of this policy, coded means that:

1. identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
2. a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879